For some reason, the folks at Public Citizen sent me a hardcopy of their Health Letter, and at the back they have a feature titled “Outrage of the Month!” This month’s example titled “More About Drug Industry Lawlessness” by Sidney M. Wolfe, M.D. is about regulatory violations by pharmaceutical companies, and it’s definitely outrageous, but not for the reason he thinks.

Eric Blumberg, deputy chief counsel for litigation at the FDA, pulled no punches. Commenting on the growing, billions-per-year monetary fraud settlements by the drug industry, he stated: “Money is clearly not doing the job; qui tam (whistleblower) complaints are still falling across my desk like snowflakes! We need to employ a ‘bigger hammer,’ to send people to jail.” He advocated, as he has previously, greater use of the so-called Park Doctrine, which allows prosecutors to hold corporate executives personally responsible for regulatory infractions without need to prove prior knowledge or intent to defraud. Blumberg pointed out that under the Park Doctrine, corporate executives and managers not only have a positive duty to seek out and take steps to eliminate fraud, but also a duty to put into place policies and procedures to prevent violations. This duty, he stated, cannot be delegated to lower-level executives or employees.

[Emphasis in the original.]

As the emphasized portion highlights — and in context Wolfe clearly thinks this is a great idea — FDA deputy counsel chief Eric Blumberg wants to eliminate the mens rea requirement in American criminal law, at least for some things that piss off the FDA. He literally wants to be able to charge drug company executives as criminals for things they they didn’t even know about.

Apparently this outrage is already used for some purposes by the FDA, because it’s mentioned in their Regulatory Procedures Manual. The summary of the Park Doctrine is chilling:

The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.

Doctor Wolfe apparently thinks this is a good thing. I wonder how he’d feel if his profession was regulated the same way, and doctors could be jailed for billing errors by their clerical staff. (Then again, his bio makes it sound like he hasn’t actually treated a patient in 40 years, so who knows?)

The mens rea requirement of the criminal law embodies the fundamental principle that punishment requires personal fault.

However, this principle also renders the criminal law a very poor mechanism for economic regulation. Regulation is not concerned with punishing wrongdoing, but with ordering human interaction so as to improve social welfare. To achieve this end, regulation must prohibit not merely conduct that is wrongful in itself (in lawyers’ Latin, malum in se), but any conduct that would thwart the overall regulatory scheme even when it is not wrongful in itself (malum prohibitum). When such regulatory offenses are embodied within the criminal law, the assumption that everyone is on notice of what the law requires–that ignorance of the law is no excuse–does not hold. Citizens may violate malum prohibitum laws without personal fault–without a guilty mind. To the extent that the mens rea requirement prohibits punishment in such cases, it undermines the efficacy of the regulatory scheme–something that suggests that regulation is best enforced administratively through civil sanctions.

Unfortunately, at an ever-accelerating rate over the course of the 20th and 21 st centuries, federal and state governments have elected to employ the criminal law as a means of achieving regulatory ends. To do so, they have created a myriad of criminal offenses known as “public welfare offenses” that would be virtually unenforceable if the government had to prove that they were committed intentionally. As a result, Congress and the state legislatures did away with the mens rea requirement for such offenses, allowing citizens to be convicted of a crime even if their violation was merely inadvertent or was entirely innocent. Further, under what is called the “responsible corporate officer doctrine”, supervisors may be punished for the inadvertent or innocent violations of their subordinates.

“Responsible corporate officer doctrine” is another term for the Park Doctrine.

It’s never been an excuse in criminal law that you didn’t know that what you were doing was a crime (no matter how many thousands of pages of law you’re supposed to obey), and I guess now it’s not even an excuse that you didn’t know a crime was going on. I guess we should be thankful that, at least for the moment, they still have to tell us what crime we’re accused of.